Ischemic Stroke
Conditions
Keywords
head-down position, ischemic stroke, rehabilitation
Brief summary
The study is designed to explore the efficacy and safety of head-down position in patients with acute ischemic stroke。
Detailed description
Currently, the guideline recommended re-perfusion such as intravenous thrombolysis and mechanical thrombectomy as the most effective treatment for acute ischemic stroke. However, the two methods are restricted by a strict time window, which greatly limits the number of the patients receiving treatment. The abundant studies have suggested that good collateral circulation can provide compensatory blood supply to save the ischemic penumbra and reduces the infarct volume, which improves the prognosis. How to improve collateral circulation in an efficient and safe way is a clinical challenge. Our recent experiment results of the animal and clinical experiments show that head-down position can significantly increase cerebral perfusion and improve neurological function. Clinically, head-down position is simple and easy to operate, and theoretically may increases brain perfusion and improve collateral circulation. A pilot randomized clinical trial is designed to investigate the effect of head-down position combined with routine rehabilitation in patients with ischemic stroke.
Interventions
In the head-down position, the body is in the supine position with the head lowered to 30 degrees
OTHERConventional Rehabilitation
The body is in the supine position without lowered head
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age ≥18 years 2. acute ischemic stroke within 10 - 30 days of onset 3. neurological deficit: 6≤NIHSS≤16 4. Large artery atherosclerosis stroke based on TOAST criteria 5. The responsibility vessels were the middle cerebral artery or internal carotid artery, and the degree of stenosis was more than 50%. 6. first stroke onset or past stroke without obvious neurological deficit (mRS≤1) 7. fully understand and cooperate with the doctor's instructions. 8. the availability of informed consent;
Exclusion criteria
1. Hemorrhagic stroke or mixed stroke 2. Combining with severe organ dysfunction 3. Past hemorrhagic stroke 4. A history of stroke with severe sequelae 5. Planning revascularization in 3 months 6. Ischemic stroke due to surgical intervention 7. participating in other clinical trials within 3 months 8. Pregnant or lactating women 9. any inappropriate patients assessed by the researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| proportion of patients with modified Rankin Score 0 to 2 | 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major vascular events | 90 days | ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction, vascular death |
| proportion of patients with modified Rankin Score 0 to 1 | 90 days | — |
| The percentage of reduction in Fugl-Meyer score | 90 days | — |
| the biggest tolerance time of head-down | 90 days | — |
| The percentage of reduction in MMSE | 90 days | MMSE，Mini-mental State Examination |
| The percentage of reduction in MoCA | 90 days | MoCA, Montreal Congnitive Assessment |
| occurrence of stroke | 90 days | stroke or TIA |
Countries
China
Outcome results
None listed